← Back to Search

Topoisomerase I inhibitors

ctDNA-Guided Therapy for Colorectal Cancer

Phase 1

Recruiting

Led By Farshid Dayyani, MD, PhD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status: ECOG performance status ≤2

Age ≥ 18 years

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug combination to see if it is effective in patients with ctDNA positive colon adenocarcinoma.

Who is the study for?

This trial is for adults with colon adenocarcinoma who have completed at least 3 months of adjuvant chemotherapy and are ctDNA positive. They must be able to swallow tablets, have a life expectancy over 3 months, and an ECOG performance status ≤2. Women of childbearing potential must use contraception.

What is being tested?

The study tests the effectiveness of TAS-102 combined with irinotecan in patients with ctDNA positive colon adenocarcinoma after surgery. It's a phase 1b trial where all participants receive this combination treatment without being randomly assigned to different groups.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding tendencies, liver enzyme changes, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am 18 years old or older.

Select...

My colorectal cancer is at Stage II, III, or IV and I'm eligible for additional chemotherapy after surgery.

Select...

My blood and organ functions are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I haven't had major surgery in the last 4 weeks or chemotherapy/radiotherapy in the last 2 weeks.

Select...

My cancer has spread to other parts of my body.

Select...

I have previously been treated with irinotecan or TAS-102.

Select...

All my side effects from cancer treatment have mostly gone, except for hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Chemotherapy, Adjuvant

Secondary study objectives

Percentage of Grade 3-5 Adverse Events

Side effects data

From 2019 Phase 3 trial • 507 Patients • NCT02500043

42%

Anaemia

38%

Neutropenia

37%

Nausea

33%

Decreased appetite

26%

Fatigue

24%

Vomiting

22%

Diarrhoea

19%

Asthenia

17%

Leukopenia

15%

Neutrophil count decreased

15%

Abdominal pain

13%

Constipation

10%

Thrombocytopenia

Blood alkaline phosphatase increased

Platelet count decreased

Abdominal pain upper

Pyrexia

White blood cell count decreased

Back pain

Lymphopenia

Dyspnoea

Aspartate aminotransferase increased

Weight decreased

General physical health deterioration

Hypoalbuminaemia

Oedema peripheral

Blood bilirubin increased

Alanine aminotransferase increased

Ascites

Abdominal distension

Dysphagia

Stomatitis

Alopecia

Hypokalaemia

Malaise

Cough

Dysgeusia

Hyperglycaemia

Hypocalcaemia

Hyperbilirubinaemia

Blood creatinine increased

Pleural effusion

Urinary tract infection

Anxiety

Insomnia

Oral candidiasis

Headache

Oedema

Arthralgia

Dizziness

Pancytopenia

Palpitations

Hypomagnesaemia

Blood urea increased

Paraesthesia

Pruritus

Hypotension

Mucosal inflammation

Upper respiratory tract infection

Productive cough

Tonsillitis

Somnolence

Nasopharyngitis

Tumour pain

Pneumonia

Spinal pain

Abdominal discomfort

Pulmonary embolism

Fall

Odynophagia

Abdominal pain lower

Flatulence

Melaena

Pain

Enzyme level increased

Shock haemorrhagic

Dyspnoea exertional

Oesophageal pain

Conjunctivitis

Protein total decreased

Groin pain

Dry skin

Cancer pain

Gastrooesophageal reflux disease

Herpes zoster

Bronchitis

Tumour haemorrhage

Dysphonia

Obstruction gastric

Infection

Septic shock

Jaundice

Acute coronary syndrome

Small intestinal obstruction

Febrile neutropenia

Tachycardia

Dry mouth

Dyspepsia

Haemorrhoidal haemorrhage

Impaired gastric emptying

Rectal haemorrhage

Toothache

Chills

Liver disorder

Respiratory tract infection

Haemoglobin decreased

Hepatic enzyme increased

Lymphocyte count decreased

Cachexia

Dehydration

Hyponatraemia

Musculoskeletal pain

Pain in extremity

Choluria

Urinary retention

Epistaxis

Hiccups

Pneumonia aspiration

Neutropenic sepsis

Haematemesis

Pallor

Vertigo

Cystitis

Decubitus ulcer

Dermatitis

Myocardial infarction

Gastric haemorrhage

Gastrointestinal haemorrhage

Upper gastrointestinal haemorrhage

Failure to thrive

Gamma-Glutamyltransferase increased

Bone pain

Myalgia

Lethargy

Neuropathy peripheral

Peripheral sensory neuropathy

Oropharyngeal pain

Nail disorder

Night sweats

Palmar-Plantar erythrodysaesthesia syndrome

Rash

Deep vein thrombosis

Embolism

Hypertension

Metastases to central nervous system

Chest discomfort

Chest pain

Ileus

Intestinal obstruction

Hepatic failure

Lower respiratory tract infection

Rhinitis

Red blood cell count decreased

Muscle atrophy

Agitation

Confusional state

Delirium

Depression

Acute kidney injury

Dysuria

Proteinuria

100%

80%

60%

40%

20%

Study treatment Arm

TAS-102+BSC

Placebo+BSC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TASIRIExperimental Treatment4 Interventions

Patients randomized to the experimental arm ("TASIRI") will be treated with TAS-102 25mg/m2 p.o. on days 1-5 and irinotecan 180mg/m2 i.v. on day 1 every 14 days. If ANC \<1500/uL on day 1 of a cycle, then G-CSF will be added on day 6 for three days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard Treatment

2014

Completed Phase 4

~2720

TAS-102

2019

Completed Phase 3

~2180